A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gingivitis
- Sponsor
- Sunstar Americas
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Bleeding on Probing (BOP)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to read, understand and sign an Informed Consent form.
- •Good general health as evidenced by the medical history.
- •Between 18 and 65 years of age.
- •Male or female.
- •Minimum of 20 teeth, excluding crowns and third molar teeth.
- •Mean whole mouth Modified Gingival Index of greater-than or equal to 2.0 at baseline.
- •Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits.
- •Willing to abstain from eating and drinking in the morning of visits, only drinking water is allowed.
- •Willing to abstain from interdental cleaning, chewing gums, oral whitening, mouth rinse and tobacco products for the study duration.
- •Able to understand and follow study directions.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change From Baseline in Bleeding on Probing (BOP)
Time Frame: 4, 12 and 24 weeks
Bleeding on probing was assessed 30 seconds after probing. A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively. BOP (%) is a percentage of sites BOP.
Change From Baseline in Modified Gingival Index (MGI)
Time Frame: 4, 12 and 24 weeks
Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation) 1. Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit 2. Mild inflammation of the entire gingival unit 3. Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit 4. Severe inflammation (marked redness and edema/hyper-trophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit. Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites.
Secondary Outcomes
- Change From Baseline in Plaque Index (PI)(4, 12 and 24 weeks)
- Change From Baseline in Probing Depth (PD)(4, 12 and 24 weeks)